Associate Director, Clinical Operations

Position Summary:

We are seeking a talented and highly motivated Associate Director, Clinical Operations to join our Clinical Development team. This position offers an opportunity to work as part of a small, dynamic team to bring novel immunomodulatory drugs to clinic.

A passion for teamwork, a can-do attitude, integrity and transparency are key attributes for this position. Come join our team!

Key Responsibilities include but are not limited to:

• Oversee scope, quality, timelines, and budget for early and/or late-stage clinical trial(s).
• Lead one or more study execution teams to ensure trials are initiated efficiently and completed on time, within budget and in compliance.
• Lead development and review of clinical and data management documents.
• Effectively communicate expectations to CROs, ensure appropriate site management and compliance with project plans, hold CROs accountable to timelines, and verify quality metrics.
• Anticipate obstacles or complex issues at the site, vendor, and study levels, and implement solutions.
• Build efficient and scalable study management and quality processes.
• Proactively identify issues for escalation, participate in problem-solving and implementation of risk mitigation.
• Ensure quality and integrity of the clinical data through management of data listings reviews.
• Drive and support development of work instructions and SOPs.
• Provide study-specific training and leadership to clinical research staff.
• Willingness to travel as necessary, consistent with project needs. (domestic and international), up to 15%.

Required Qualifications:

• BSc in natural or health sciences (biology, pharmacology, pharmaceutical sciences, or equivalent) preferred.
• 10+ years of clinical operations experience with both early and late-stage immunology clinical trials preferred.
• Strong knowledge of clinical trial process, including working knowledge of all functional areas of clinical trials and regulatory requirements; prior inspection readiness experience preferred.
• Exceptional project management skills, organizational and problem-solving skills.
• Eager to learn with a collaborative, team-oriented mindset.
• Excellent written and verbal communication skills with an ability to express complex ideas to study personnel at research and clinical institutions.
• Diligent, highly motivated self-starter with a strong growth mindset and a positive “can-do” attitude towards assigned tasks.
• Must be currently able to fulfill the onsite requirement of this position.

As TRexBio advances its first wholly owned asset into Phase 1 clinical trials, the company is seeking an experienced and dynamic Associate Director, Clinical Operations to lead and manage operational aspects of the company’s clinical trials.

Reporting directly to the Senior Director, Clinical Operations, the Associate Director will partner with the cross-functional team to execute on the clinical strategy of the company. The ideal candidate will bring strong expertise in early-phase clinical trials, a collaborative management style, and a passion for advancing innovative therapies.

TRexBio offers a very competitive benefits including medical, dental, vision, short/long term disability, life insurance as well as 401(k) match, bonus and paid time leave.

This position is open to direct applicants only. We are not engaging third-party recruiters or agencies at this time.

Our Culture:

At TRexBio, you will have the opportunity to work with amazingly smart humans who strive to make the world a better place. In addition to our team-centric culture, we believe that your individual creativity will help us to be our best. Our staff happy hours, organized by our Culture Club, bring us all together in creative and social activities. Our colleagues admire and respect one another. We celebrate our wins, update company news and acknowledge each other’s achievement weekly and monthly at all company meetings that celebrate our work and our people.

TRexBio is proud to be an AA/EEO employer and all qualified candidates will receive consideration without regard to characteristics protected by applicable local, state, or federal law, such as race, color, sex, age, religion, national origin, physical or mental disability, pregnancy, marital status, veteran or military status, genetic information, or sexual orientation.